Sunovion Pharma resubmits application to USFDA for sublingual Apomorphine to treat Parkinsons disease

New Delhi: Sunovion Pharmaceuticals Inc. (Sunovion) recently announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson's disease (PD), which was resubmitted on November 21, 2019. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 21, 2020.

Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF, delayed ON/partial ON and end-of-dose wearing OFF. OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person's ability to maintain everyday activities. OFF episodes may worsen in frequency and severity over the course of the illness.1 While OFF episodes are experienced by 40 to 60 per cent of people with PD, there are limited treatment options available to treat OFF episodes when they occur.

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"The unpredictable nature of OFF episodes can be extremely challenging and disruptive to the daily lives of people living with Parkinson's disease as well as their care partners," said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. "We look forward to working with the FDA over the remaining review period."

"People with Parkinson's have shared that OFF episodes can be disruptive and hamper their quality of life. New treatments could mean greater symptom control for more people, improving their ability and confidence to navigate daily life with the disease," said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation for Parkinson's Research.

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